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Voluntary Nationwide Recall of all Liquid Products Manufactured by Pharmatech LLC and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories Due to Possible Product Contamination

As a precautionary measure, the distribution firms Leader Brand, Major Pharmaceuticals, and Rugby Laboratories are jointly issuing a nationwide voluntary recall of all lots within expiry of all liquid products manufactured by PharmaTech LLC at its FDA registered facility in Davie, Fla. due to possible product contamination.

The distribution firms are committed to patient safety and are partnering with the Food and Drug Administration to notify customers who may be in possession of liquid products manufactured by PharmaTech LLC. Please see the below list of affected products.

The products subject to this recall were distributed nationwide to wholesale and retail facilities, including hospitals and pharmacies. Through recent communication with FDA, the distribution firm Rugby Laboratories learned of a potential issue with a product manufactured by PharmaTech LLC. The FDA informed Rugby Laboratories that it received several adverse event reports of B. cepacia infections in patients, which may be linked to PharmaTech LLC manufactured Diocto Syrup or Diocto Liquid (docusate sodium solutions). In response, Rugby Laboratories issued a voluntary recall on August 3, 2017, of the PharmaTech LLC manufactured Diocto Syrup and Diocto Liquid. As a precautionary measure based on additional information received from the FDA, the three distribution firms are recalling all lots within expiry of all liquid products manufactured by PharmaTech LLC.

The distribution firms are notifying their distributors and customers by recall letter and are arranging for return of all recalled products. Consumers, pharmacies, and healthcare facilities that have product being recalled should stop using and dispensing the product immediately.

Consumers with questions regarding this recall should contact Rugby Laboratories/Major Pharmaceuticals Customer Support at 1-800-645-2158, available Monday through Friday 8 a.m. – 8 p.m. EST or Leader Customer Support at 1-800-200-6313 option #1 Monday through Thursday 8 a.m. – 7p.m. and Friday 8 a.m. – 5 p.m EST. Consumers can contact their physician or healthcare provider if they have additional questions about this product.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax:

This recall is being conducted with the full knowledge of the U.S. Food and Drug Administration.

LEADER BRAND

Liquid Multivitamin Supplement for Infants and Toddlers 50 mL,

UPC: 096295128611

ALL LOTS

Liquid Vitamin D Supplement for Breastfed Infants 400 IU 50 mL,

UPC: 096295128628

ALL LOTS

MAJOR PHARMACEUTICALS

Certa-Vite Liquid

236ML

00904-5023-09

ALL LOTS

Poly-Vita Drops

50ML

00904-5099-50

ALL LOTS

Poly-Vita Drops W/Iron

50ML

00904-5100-50;

ALL LOTS

Ferrous Drops Iron Supp

50ML

00904-6060-50

ALL LOTS

D-Vita Drops

50ML

00904-6273-50

ALL LOTS

Tri-Vita Drops

50ML

00904-6274-50

ALL LOTS

Senna Syrup

237ML

00904-6289-09

ALL LOTS

RUGBY LABORATORIES

C Liquid 500mg

118ML

00536-0160-97

ALL LOTS

Diocto Liquid 50mg/5ml

473ML

00536-0590-85

ALL LOTS

Ferrous Sulfate Elixir

473ML

00536-0650-85

ALL LOTS

Fer Iron Liquid 50ML

50ML

00536-0710-80

ALL LOTS

Senexon Liquid

237ML

00536-1000-59

ALL LOTS

Diocto Syrup 60MG/15ML

473ML

00536-1001-85

ALL LOTS

Aller Chlor Syrup

120ML

00536-1025-47

ALL LOTS

Calcionate Syrup

16OZ

00536-2770-85

ALL LOTS

Cerovite Liquid

236ML

00536-2790-59

ALL LOTS

D3 400iu Liquid

50ML

00536-8400-80

ALL LOTS

Poly-Vitamin Liquid

50ML

00536-8450-80

ALL LOTS

Tri-Vitamin Liquid

50ML

00536-8501-80

ALL LOTS

Poly-Vitamin W/Iron Liquid

50ML

00536-8530-80

ALL LOTS

About Leader™

The Leader™ Brand product line is a broad assortment of quality, healthcare and personal care items available at authorized pharmacies nationwide. A broadly-based distribution network and strong customer loyalty enables Leader™ to offer products with the same active ingredients as nationally-advertised brands, but at significant savings to customers.

About Major Pharmaceuticals

For more than 30 years, Major® has been offering a broad and expanding portfolio of Rx unit dose, bulk and OTC options focused on supporting patient care efforts and providing economic value.

About Rugby® Laboratories

Rugby® Laboratories is a leading provider of high-quality Over the Counter, vitamin, and nutritional supplement products. With more than 40 years of history, Rugby® has been able to build out a comprehensive portfolio of products designed to enhance the quality of life for our consumers while reducing the cost of purchasing their medications.

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About The FDA

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.